Quality evaluation of Liver-protection Agent based on HPLC fingerprint and simultaneous determinations of multiple components / 中草药

ABSTRACT

Objective To establish HPLC fingerprint strategy to simultaneously determine nine components in Liver-protection Agent, including loganin, paeonflorin, scutellarin, baicalin, baicalein, deoxyschizandrin, schisandrin, schizandrin C, and ursolic acid, and provide a scientific basis for the quality control of Liver-protection Agent and related medicinal preparations. Methods The analytical analysis was performed on an Agilent 1260-HPLC system equipped with a VWD detector and SB-C18 reversed phase column (Zorbax 150 mm × 4.6 mm, 5 μm). The analytes were eluted using a gradient mixture of two solvent solvent A was distilled deionized water containing 0.1% ortho-phosphoric acid and solvent B was 100% acetonitrile. The mobile phase flow rate was 1.0 mL/min. The separation temperature was 30 ℃. The detection wavelengths were 236, 280, and 210 nm. The injection volume was 5 μL. Common patterns of HPLC fingerprints for 10 batches of Liver-protection Agent medicinal preparations were established, and chemometric analysis method was employed to analyze the hidden information. At the same time, methodological study was conducted for determinations of multiple components including loganin, paeonflorin, scutellarin, baicalin, baicalein, deoxyschizandrin, schisandrin, schizandrin C, and ursolic acid. Results The HPLC fingerprint strategy of Liver-protection Agent medicinal preparation had been set up, and 37 common peaks had been identified with the similarity of more than 0.9. Moreover, the samples were roughly divided into four categories by the methods of the systematic cluster analysis and principle component analysis. After validating the multiple component quantitative analysis condition through methodology, the average recovery rate was between 95.13% and 104.8%.The average mass concentration of loganin, paeonflorin, scutellarin, baicalin, baicalein, deoxyschizandrin, schisandrin, schizandrin C, and ursolic acid in ten batches of Liver-protection Agent was 216.3-223.0, 126.1-137.1, 144.7-149.0,1 623.1-1 992.7, 481.9-520.0, 14.9-18.7, 33.8-37.0, 2.9-3.7, and 39.7-43.6 mg/L, respectively. Conclusion The combination methods of HPLC fingerprint and simultaneous determinations of multiple components are rapid, simple, and reproducible, which can be adopted as one of the quality control methods for Liver-protection Agent and related medicinal preparations.